PMA P210003S005
- Device
- ARCHITECT HBsAg Next Qualitative / Next Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P210003
- Supplement
- S005
- Decision date
- 2023-01-30
- Approval order statement
- Switch to a new supplier of a noncritical manufacturing ingredient.
Current openFDA PMA Record#
- Device
- ARCHITECT HBsAg Next Qualitative / Next Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P210003
- Supplement
- S005
- Decision date
- 2023-01-30
- Decision code
- OK30
- Date received
- 2023-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Switch to a new supplier of a noncritical manufacturing ingredient.